AnemiaPhase 3NCT00628043
Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
A Phase 3 study testing epoetin beta in people with Anemia, run by Chugai Pharmaceutical at 6 sites in Japan.
Trial summary
This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 6 sitesJapan
- Study dates
- May 2008to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung cancer or gynecologic cancer patients
- Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
- 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
- 20 - 79 years old
- Performance status: 0 - 2
- No iron deficiency anemia
Who cannot join
- Red blood cell transfusion within 4 weeks before treatment
- Erythropoietin therapy within 8 weeks before treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Chubu Region
Chūbu
Chugoku/Shikoku Region
Chugoku/Shikoku
Hokkaido/Tohoku Region
Hokkaido/Tohoku
Kanto/Koshinetsu Region
Kanto/Koshinetsu
Kinki/Hokuriku Region
Kinki/Hokuriku
Kyushu Region
Kyushu
About this study
Official title: A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.
- Conditions
- Anemia
- Being tested
- epoetin beta, placebo
- Keywords
- Cancer, patients, with, chemotherapy, induced, anemia
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin betaDrug
Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
placeboDrug
Subcutaneous administration of placebo once-weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| EPOCH | Experimental | Not described Receives: Drug: epoetin beta |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
Measured: 16 weeks
Secondary outcomes (3)
Change in Hb
Measured: 16 weeks
Change in FACT- total Fatigue Subscale score (FSS)
Measured: 16 weeks
Requirement for RBC transfusion
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yoshito Suzuki, Study chair, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628043
- Sponsor's protocol ID
- EPO316 JP
- Status last verified
- Sep 2009
- First submitted
- 24 Feb 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
- ClinicalTrials.gov ID
- NCT00628043
- Acronym / sponsor ID
- EPO316 JP
- Conditions
- Anemia
- Keywords
- Cancer, patients, with, chemotherapy, induced, anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPOCH | Experimental | Drug: epoetin beta |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lung cancer or gynecologic cancer patients
- Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
- 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
- 20 - 79 years old
- Performance status: 0 - 2
Key exclusion criteria (2 listed)
- Red blood cell transfusion within 4 weeks before treatment
- Erythropoietin therapy within 8 weeks before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin betaSubcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks | Drug | EPOCH |
| placeboSubcutaneous administration of placebo once-weekly for 12 weeks | Drug | placebo |
Primary outcome
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
Time frame: 16 weeks
3 secondary outcomes
Change in Hb
Time frame: 16 weeks
Change in FACT- total Fatigue Subscale score (FSS)
Time frame: 16 weeks
Requirement for RBC transfusion
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshito Suzuki study chair
Chugai Pharmaceutical
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin beta in people with Anemia, run by Chugai Pharmaceutical at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2009.